Poor adherence to medication schedules is a recognized medical problem, costing an estimated $100 billion a year (Improving Medication Adherence, Archives of Internal Medicine 2006, 166:1802-1804). Failing to comply with pharmacological therapies leads to over approximately 125,000 deaths in the US each year, twice the number of people killed in automobile accidents (http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=904). Almost 30% of all hospital admissions for people over the age of 65 are directly attributable to medication non-compliance (Archives of Internal Medicine 1990; 150: 841-845). Nearly $48 billion in annual costs result from unnecessary medication-induced hospitalization (Archives of Internal Medicine—October 1995). Approximately 40% of people entering nursing homes do so because they are unable to self-medicate in their own homes (Feasibility Study, Biomedical Business International, January 1988). About one-half of the 1.8 billion prescriptions dispensed annually are not taken correctly, contributing to prolonged or additional illnesses (Medications and the Elderly, Ch. 4 pp 67-68, 75).
Care management and Health Plans currently rely on labor-intensive and costly intervention programs to improve medication compliance. Directly Observed Therapy (DOT) programs employ a health care worker to directly administer, observe and document a patient's ingestion of a medication.
Patients who must take medication in pill form often use a multi-compartment dispenser to help organize the task of taking the proper medication at the proper time. Patients who must take many pills per day at different times of the day frequently use a daily manual dispenser that has four compartments for one day. These compartments are designated AM, NOON, PM, Bed, or Breakfast, Lunch, Dinner, Bed, or some other set of designations, for instance, by time. The four compartments can be integral, or can be individual small boxes that are retained in a day-frame, so that each can be individually manipulated. Pill organizers typically can have seven of such daily four compartment boxes, arranged according to the seven days of the week. Such weekly organizers can typically include a frame that removably retains each of seven daily dispensers, so that each one can be individually removed and manipulated. Rather than four compartments, a daily system can have more or less compartments, depending on the complexity of the patient's medication regime.
Such manual medication systems are simple, and have both advantages and disadvantages. The advantages include that they are inexpensive and relatively easy to set up and use. A patient or a patient's aid determines which medications are required for each day, and the times of the day that they are required. The required pills are placed into the corresponding compartments, the compartments are closed and each day-set is put into the week-frame for safe-keeping. The patient or the patient's aide opens the appropriate compartment at the appointed times, removes the medication, and the patient consumes it. It is refilled with the proper medications at some time before the next day or week when the compartment or day-set is required to be used again and the process begins again. Other advantages are that the day-set or week-frame can be relatively easily transported to accompany the patient if the patient needs to be away from home for a day or more. They can be cleaned relatively easily. They are arranged physically in a manner that mimics a daily organizer, such as a calendar or a day-planner, and thus, are clear, typically, as to which medication has been designated to be taken at which time(s).
Medication organizing equipment as described above does have disadvantages. Some disadvantages relate to loading the medications into the equipment, and some relate to removing the medications. Further, these manual systems provide only rudimentary record keeping functions. Turning first to the loading disadvantages, many patients are on complicated medication regimes, and thus, it can be complicated to ensure that the correct medication is placed in the compartment that corresponds to the correct time to take that medication. Duplicate pill placement can take place, which could result in an overdose. Or, a placement can be inadvertently omitted, which might result in an under dose. Some patients can find it psychologically daunting to face the task of organizing all of the medications. Or they can simply be unable to do so cognitively, especially if their condition affects their cognition.
Turning to the dispensing disadvantages, a typical day-set contains four compartments, and a typical week-set contains seven day-sets, for a total of twenty-eight dose medication compartments. A patient might become confused as to which medication compartment to use at any given time. Even if not confused, a patient might open a medication compartment from the correct day, but the wrong time, or, perhaps, the correct time, but from the wrong day of the week (for instance, regarding a medication that is taken only every other day, or for three consecutive days, but not the following four). A patient can forget to take any medication at a prescribed time, open a wrong compartment or simply not take the medication for another reason. Additionally, a patient might forget that they have taken a given dose of medication, and might take an additional dose. If two people share responsibility for a patient, including, perhaps, the patient himself/herself, both people might give the patient a dose of the same medication, erroneously, resulting in an overdose.
Further disadvantages relate to the lack of real time remote visibility for caregivers or third parties to monitor compliance with the medication schedule. It is also beneficial to generate accurate records reflecting when medication has been taken, or accessed, and what medication has been taken.
In recent years, automated and semi-automated systems have been developed. Many of these systems have disadvantages of their own. They typically have many and complicated features. The user interfaces are overly complicated, and include multiple data read-outs and opportunities for input, similar in complexity to media recording equipment, or kitchen appliances, many of which remain un-programmed, with some features unused. Such systems intimidate and confuse many users, particularly elderly and infirm who require significant amount of medication at specific times. Ironically, the more one is in need of the system, due to the complexity of their drug regime, the greater the probability that they might be unable to use such a modern system. They are difficult to set-up and to program the drug regime. They are sometimes also difficult to use for dispensing medication, because of complex user interaction controls.
It has also been recognized that even audible and visual cues for taking the correct medication at the correct time can be difficult to follow, particularly in patients that suffer from diminished cognitive abilities or general confusion. This can be highly disadvantageous, as the patient can take the wrong medication at the wrong time, or take too many doses from the container.
Advances in telecommunications have made possible the integration of various systems into smaller devices. Telephones and other handheld electronic devices have been furnished with micro-recording devices, small media recorders and linked to the internet to provide a capability for real-time media links. Vulnerable patients now find themselves in instant communication with service providers in case of accidents. This is particularly useful in promoting independence and self-reliance among those individuals. But while this is convenient, it can lead to a plurality of devices with overlapping telecommunications capabilities, providing potential confusion to less-functional users.
It is therefore desirable to provide a medication dispensing system that is easy to use, easy to reload, can provide audible and visual cues and also ensures that only the correct medication can be taken at a particular time. The dispenser should be capable of monitoring compliance and communicating with various caregivers and other concerned individuals. The system should also be sized so that an elderly, or otherwise challenged, individual can easily see and manipulate the various compartments for dispensing medication.